Senior Statistical Programmer / Principal Statistical Programmer

Job Role : Senior Programmer

Job Type : C2H

Tenure : 6 monoths (again Extend)

Work Mode : Hybrid

Working Days : 5 Days

Notice Period : Immediate Joiners (or) 15 Days

About the Job:

We are seeking a highly skilled and analytical Senior / Principal Statistical Programmer to join our team supporting Global clinical trials. In this role, you will lead statistical programming deliverables, ensuring the generation of submission-ready packages across multiple therapeutic areas. You will act as a core technical anchor, developing high-quality datasets and outputs while establishing strict validation standards.

Roles & Responsibilities

• Dataset Development: Design and develop SDTM and ADaM datasets in strict compliance with CDISC standards.
• Reporting Outputs: Generate complex Tables, Listings, and Figures (TLFs) to support Clinical Study Reports (CSR), safety evaluations, and efficacy reporting.
• Submission Preparation: Manage Case Report Form (CRF) annotations, specification mapping, Define.xml setup, and the final preparation of CRT packages.
• Compliance & Validation: Troubleshoot and resolve compliance errors using Pinnacle 21 validation tools.
• Quality Control: Perform rigorous independent code validation of critical trial safety and efficacy deliverables using PROC COMPARE, PROC SQL, and PROC FREQ.
• Automation: Author, test, and maintain reusable SAS macros to optimize data ingestion and automate reporting structures.
• Cross-Functional Collaboration: Partner actively with global Biostatistics, Data Management, and Clinical teams to manage timelines and maintain data integrity.
• Advanced Analytics: Leverage modern open-source toolsets (R programming packages like dplyr, tidyr, ggplot2) for exploration and advanced data visualization.

Desired Candidate Profile:

• Experience: 5 to 8 years of solid statistical programming experience within the pharmaceutical industry or clinical research organizations (CROs).
• Domain Expertise: Prior hands-on experience handling Phase II and Phase III clinical trials, with specialized familiarity in therapeutic areas such as Oncology, CNS, or Endocrinology.
• Technical Command: Advanced mastery of Base SAS, SAS Macros, and SQL query creation alongside basic analytics proficiency in R.
• Standards Mastery: Absolute clarity on CDISC implementation rules, controlled terminology updates, and regulatory standards.
• Education: Master of Computer Applications (MCA), M.Sc./B.Sc. in Statistics, Computer Science, Life Sciences, or a related scientific discipline.

Interested Candidates can reach us :

Email : [email protected]

Whatsapp : 9394368397

Thanks & Regards,

Manpower Group